Positive results of first-in-human clinical trial of PreciseInhale now published in European Journal of Pharmaceutical Sciences

(Stockholm, 11 March 2024) Positive results from Inhalation Sciences’ first-in-human clinical study of its aerosol generating system PreciseInhale® are now published in a peer-reviewed paper in the European Journal of Pharmaceutical Sciences. The results demonstrate that PreciseInhale® provides greater precision and control than aerosol dosing carried out with a standard commercial inhaler, and can be used for ‘regional targeting’, exposing specific regions of the lungs to a targeted aerosol. The topline results were first communicated on December 20, 2021.

The paper is titled Regional lung targeting with a fluticasone/salmeterol aerosol using a bolus breath hold method of the PreciseInhale® system: A first evaluation in humans. It was published on March 7. Its voluminous data include graphic abstracts and a full account of the Study which concluded at the end of 2021, reaching its clinical objectives and  making PreciseInhale® the first aerosol generation system that can be used from drug discovery through to first use in humans, unlocking a new addressable market estimated at SEK 5 billion by Inhalation Sciences.  

The paper concludes: “the PreciseInhale® system provided better control of actuation, aspiration, and dispensation of aerosols from the clinical inhaler and thereby delivered higher quality readouts of pharmacokinetic parameters such as tmax, Cmax, and AUC. Improved performance, using the PI system, can likely also be employed for studying regional selectivity of other responses in the lungs, for use in drug development”.

ISAB founder and CSO Per Gerde: “as the first aerosol generating system that can be used from drug discovery, through preclinical studies into first uses in humans, PreciseInhale reduces the risk and translational errors throughout the drug development journey”.

ISAB CEO Manoush Masarrat: “for research companies who develop new inhaled therapies and want to stay on the same platform from discovery all the way into early clinical testing, PreciseInhale will allow winner candidates to be selected earlier, significantly reducing costs. Clinical validation of PreciseInhale gives the entire inhalation research sector new capabilities and a new benchmark for precision and control in aerosol testing”.

Access the new paper here: https://www.sciencedirect.com/science/article/pii/S0928098724000538